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IRCT2017092023861N7 IRCT 2017-10-25 Vice chancellor of research, Iran University of Medical Science The effect of synbiotic supplementation on inflammation in Breast Cancer survivors with Lymphedema The effect of synbiotic supplementation on the serum concentration of inflammatory cytokines and leptin in Breast Cancer survivors with Lymphedema 2017-12-22 anticipated 88 Complete https://irct.ir/trial/20290 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 88 identified, 22 blocks will be produced using the online site (www.sealedenvelope.com). In order to apply the concealment in the randomization process, unique codes will be used on the pharmaceutical boxes, which will be generated by the software. By entering each individual into a study based on the sequence produced, the packet of the drug in which the code is registered will be assigned to the individual. During the research, the random list has been provided to the statistics consultant and patients, executor of plan and everybody who takes part in measuring indicators will not be informed of the assigned groups. 2-3 lymphedema. Intervention 1: Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week) + consumption of synbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38.5 mg fructooligosaccharide, once daily for 10 weeks. synbiotic supplement will be purchase from Zist takhmir company. Intervention 2: Control group : weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week) + placebo consists of ( lactose,Magnesium Stearate, talk, silicon dioxide) once daily for 10 weeks. Placebo will be purchase from Zist takhmir company.
public Dr Mitra Zarrati
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
Tehran Iran (Islamic Republic of) +98 21 8670 4814 zarrati.m@iums.ac.ir Iran University of Medical Science scientific Dr Mitra Zarrati
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
Tehran Iran (Islamic Republic of) +98 21 8670 4814 zarrati.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: women with unilateral breast cancer related lymphedema ; breast cancer lymphedema in stage 2; Age range between 18 to 60 years ; BMI between 25 to 35 Kg/m2 ; At least one month has passed since the last treatment such as radiotherapy; Willingness to participate in the study ; Non-inclusion criteria: Use of multivitamin minerals and omega 3 supplements up to 1 month before the study began; Inflammatory diseases such as heart failure, pulmonary, kidney and diabetes; autoimmune diseases such as rheumatoid arthritis; Acute and chronic infection; taking Probiotics supplementation from 6 months before study; having a weight loss diet in Length 6 months before the study ; Smoking and Alcohol consumption; Lymphedema due to other cancers; Exclusion criteria: Cancer recurrence during the study; Metastasis; Diseases leading to edema such as renal, cardiopulmonary and pulmonary failure during the study; Infectious diseases during the study; Consumption of food and supplements containing probiotics during the study; Failure to follow the weight loss diet; Consumption less than 56 capsules; Unwillingness to continue cooperation 18 years 60 years Female C50.9 Breast, unspecified Treatment - Drugs Placebo Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week) + consumption of synbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38.5 mg fructooligosaccharide, once daily for 10 weeks. synbiotic supplement will be purchase from Zist takhmir company. Control group : weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week) + placebo consists of ( lactose,Magnesium Stearate, talk, silicon dioxide) once daily for 10 weeks. Placebo will be purchase from Zist takhmir company. Tumor necrosis factor alpha. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA. Interleukin 1. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA. Interleukin 6. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA. Leptin. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA. HsCRP. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: immunoturbidimetry. Volume of lymphedema. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: water tank technique. BMI. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Weight ratio (kg) to squared height (m). Waist circumference. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: meter. Waist to hip ratio. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Calculate. Skinfold thickness. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: caliper. Nutritional status. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer. Physical Activity. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: IPAQ questionnaire. Vice chancellor of research, Iran University of Medical Science Approved 2017-07-17 Ethics committee Of Iran University Of Medical Sciences Iran University of Medical Sciences, next to the Milad hospital, the intersection Of sheikh Fazlallah and Shahid Chamran, Hemmat expressway Tehran Iran (Islamic Republic of)